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IP Alert: Calculating Patent Term Extension for FDA Delay: Original Patent or Reissue Patent Issue Date?

October 31, 2023

The Federal Circuit appeal in Merck Sharp & Dohme B.V., Merck Sharp & Dohme, LLC v. Aurobindo Pharma USA, Inc. et al., concerns whether patent term extension (PTE) for regulatory delay, in particular delay for FDA drug approval, should be calculated from the date the original patent issued or the date the reissue patent issued. The appeal is from the decision of the U.S. District Court for the District of New Jersey in In re Sugammadex. The patent at issue, assigned to Merck, is reissue patent RE 44,733 listed in the Orange Book for the Bridion® intravenous product containing sugammadex as the active ingredient. Bridion® is used to reverse a neuromuscular blockade induced by rocuronium and vecuronium in general anesthesia.

Aurobindo contends the district erred in upholding five years of PTE for the ’733 reissue patent, which was calculated from the issue date of surrendered original patent rather than the issue date of the ’733 reissue patent.

As background, the original patent was issued in December 2003. In early 2004, Merck filed an application for an Investigational New Drug. Merck then filed a New Drug Application (NDA) in 2007. Merck’s predecessor-in-interest filed an application for a reissue patent on March 28, 2012. The ’733 reissue patent issued on January 28, 2014. The ’733 reissue patent includes claims 1-9 from the original patent and twelve new narrower dependent claims (10–21) added in the reissue. Merck surrendered the original patent. The FDA approved Merck’s NDA on December 15, 2015.

Within months of receiving the FDA approval on its NDA, Merck applied for the maximum allowable five years of PTE. Merck’s application for PTE identified original claims (including claim 4) and new claims (e.g., claims 12 and 21) as covering sugammadex.

On appeal, Aurobindo maintains the PTE calculation for Merck’s reissue patent should have been based on the January 28, 2014, issue date for the reissue patent. Aurobindo points to 35 U.S.C. § 156(c) referring to “regulatory review period for the approved product” that “occurs after the date the patent is issued.”

Depending on whether the delay period is calculated from the issue date of Merck’s original patent or the ’733 reissue patent has a significant effect on the PTE because the regulatory review period is longer if calculated from the date of the original patent as compared to the ’733 reissue patent. According to Aurobindo, the delay period should be calculated from the issue date of the reissue patent, which equates to 686 days of PTE. The USPTO accorded Merck five years of PTE, which was based on the issue date of the surrendered original patent. According to Aurobindo’s calculation, the ’733 reissue patent would have expired on December 14, 2022. By the USPTO’s PTE calculation, the patent expires on January 27, 2026. The difference is significant because the longer the patent is alive, the longer Merck can capitalize on its patent coverage of the Bridion® intravenous product with sugammadex as the active ingredient.

As an aside, while the MPEP is not law binding a federal court, MPEP §2766 states that “[w]ith respect to calculating the amount of extension to which the reissued patent is entitled to receive, so long as the original patent claimed the approved product and the reissued patent claims the approved product, the original patent grant date would be used to calculate the extension to which the reissued patent would be entitled.”

The district court did not invalidate the ’733 reissue patent under 35 U.S.C. 282(c) by overturning the five years of PTE. The district court concluded “understanding § 156(c) within its place in the statutory scheme and alongside other relevant provisions of the Patent Act—as this Court must—it is clear that, for reissue patents seeking patent term extensions, ‘the date the patent is issued’ refers to the date the original patent issued.” In re Sugammadex.

The Federal Circuit’s decision in this case will be important for calculating PTE for reissue patents. Fitch Even attorneys are closely monitoring this appeal and will provide updates as the appeal progresses.

For more information on this case, please contact Fitch Even partner Kendrew H. Colton, author of this alert.

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